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Study of Sculptra for Mid-Face Volume and Skin Changes

This study is looking at how Sculptra® injections affect the skin in the mid-face area. Researchers want to see if Sculptra can improve volume deficiency, skin looseness (laxity), and sun-damaged (photo-aged) skin. You might be able to join if you are a woman between 45 and 65 years old with moderate to severe wrinkles in your cheeks. The main goal is to measure changes in your mid-face using special imaging tools after Sculptra treatment. The study is currently unclear on its recruitment status and plans to enroll 25 participants.

Study design
This is an interventional study with a planned enrollment of 25 women. It is not specified if it is randomized or blinded.
What's involved
Participants will receive Sculptra injections in their cheeks and will have imaging assessments at 4, 8, 12, 16, and 20 weeks after the initial treatment. You will also need to be photographed at each visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 20 weeks after their initial treatment to assess structural changes in the mid-face.

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NCT07399028

A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Recruiting
NAAges 45–65InterventionalTreatment
Galderma R&D
~25 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Sculptra®

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging
Measured over 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline

Conditions

Volume Deficiency in the Mid-Face
Skin Laxity
Photo-aged Skin

Explore related trials

Cutis LaxaPhoto-aged SkinVolume Deficiency in the Mid-Face

Where it's being run

1 sites across 1 states
New York1

Who to contact

Christina Uong
[email protected]
212-508-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult subjects aged 45-65 years old
Females only
Subject with moderate-to-severe cheek wrinkles on the GCWS
Subject with intent to undergo correction of cheek wrinkles on both sides of the face
Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes
Subject willing to be photographed at each visit.
Subjects willing to stop using current facial skincare products for the duration of the study.
Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.
Ability to read, understand and give consent for participation in the study.
Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.

Exclusion

Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

What this trial measures

  • Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline

    Images taken with VISIA imaging system and an imaging system using tomography technology at baseline and post-baseline timepoints will be compared to assess structural changes in cheeks.